Effect of High Altitude Exposure, Acclimatization and Re-exposure on Right Ventricular Function in Lowlanders

NCT ID: NCT02730156

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-09
• Study Completion Date: 2016-05-04

Brief Summary

Prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude

Detailed Description

Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period.

A second altitude sojourn cycle with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile), then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland; those are repeated in the second altitude sojourn cycle. Measurements will be conducted by qualified specialists using a portable ultrasound device.

Conditions

Effect of High Altitude

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Altitude exposure

Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude

Group Type: EXPERIMENTAL

Altitude exposure

Intervention Type: OTHER

Altitude exposure

Interventions

Altitude exposure

Altitude exposure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Born, raised and currently living <800m
• No overnight stay at altitudes >1500 m 4 weeks before the study

Exclusion Criteria

• Previous altitude intolerance to altitude <3000 m
• Pregnancy
• Health impairment, which requires regular treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad E Bloch, MD

Role: STUDY_CHAIR

University of Zurich

Locations

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

REB15-2709_V2

Identifier Type: -

Identifier Source: org_study_id